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Docetaxel in Treating Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00003565
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.


Condition or disease Intervention/treatment Phase
Bladder Cancer Breast Cancer Head and Neck Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: docetaxel Phase 2

Detailed Description:

OBJECTIVES:

  • Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors.
  • Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations.
  • Determine the CYP3A4 genotype and P-glycoprotein (P-gp) expression and their relationship to docetaxel clearance in these patient populations.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients
Study Start Date : September 1998
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: docetaxel
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.
 Drug: docetaxel


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven unresectable solid tumors (e.g., lung, breast, head and neck, bladder)
  • Clinically suitable for treatment with single agent docetaxel
  • Caucasian (at least 2 generations originating in any of the original peoples of Europe, North Africa, or the Middle East) OR
  • African American (at least 2 generations originating in any of the black racial groups of Africa)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • 0-2

Hematopoietic:

  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 1.5 times ULN AND
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • BUN no greater than 1.5 times ULN
  • Creatinine no greater 1.5 times ULN

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow transplantation

Chemotherapy:

  • No prior docetaxel
  • Prior paclitaxel allowed
  • 1 or 2 prior chemotherapy regimens allowed
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormones for disease related conditions
  • Concurrent steroids for adrenal failure allowed

Radiotherapy:

  • At least 2 weeks since prior radiotherapy
  • Palliative radiotherapy allowed except whole brain irradiation for CNS disease

Surgery:

  • Not specified

Other:

  • At least 48 hours since prior or concurrent ethanol (CYP3A enzyme inducer) or grapefruit juice (CYP3A enzyme inhibitor)

  • At least 7 days since prior or concurrent CYP450 inducing drugs:

    • Antiseizure medications: phenobarbital, phenytoin, carbamazepine, or lamotrigine
    • Anti-TB therapy: rifampin, isoniazid, or sulfinpyrazone

  • At least 7 days since prior or concurrent CYP450 3A inhibiting drugs:

    • Macrolides: erythromycin, clarithromycin, azithromycin, or roxithromycin
    • Azoles: ketoconazole, fluconazole, or itraconazole
    • Other antibiotics: metronidazole or chloramphenicol
    • Anti-HIV drugs: ritonavir, indinavir, nelfinavir, or delavirdine
    • Immunosuppressive agents: cyclosporine
    • Antidepressant agent: nefazodone
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003565


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Lionel Lewis, MD Norris Cotton Cancer Center
More Information
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Publications of Results:

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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003565    
Other Study ID Numbers: CALGB-9871
U10CA031946 ( U.S. NIH Grant/Contract )
CALGB-9871
CDR0000066631 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage IV nasopharyngeal cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
 unspecified adult solid tumor, protocol specific
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
pulmonary carcinoid tumor
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III verrucous carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action